The First Affiliated Hospital with Nanjing Medical University
Phase
Phase 2
Started
2025-01-01
Last updated
2025-08-11
Condition(s) studied
Breast Cancer
Investigational drug(s) / intervention(s)
Exemption from additional radiotherapy on the tumor bed after surgery
Exemption from additional radiotherapy on the tumor bed after surgery: For patients who met the inclusion criteria and were enrolled, postoperative tumor bed boost radiotherapy was waived, and only whole breast and/or regional lymph node irradiation was administered.
Study summary
This study is a multicenter, single-arm, phase II clinical trial, aiming to evaluate the safety and efficacy of tumor bed dose escalation radiotherapy for patients with primary breast lesions achieving pCR (ypT0) after neoadjuvant chemotherapy and breast-conserving surgery.
Eligibility
Sex
FEMALE
Min age
30 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
(1) Voluntary participation, good compliance, able to cooperate with the trial observation, and having signed a written informed consent form; (2) Confirmed as invasive cancer through pathological tissue examination, and received baseline breast MR or PET/MR examination before neoadjuvant therapy; (3) Received the standard neoadjuvant treatment plan recommended by the guidelines based on molecular typing; (4) Single lesion, initially diagnosed as cT1-3N0-3a; (5) Underwent breast-conserving surgery, with negative surgical margins and a margin distance of ≥1mm, and achieved pCR of the primary breast lesion after NAC (ypT0); (6) Age 30-75 years, ECOG score 0-1; (7) Met the basic requirements for adjuvant radiotherapy, including basically normal peripheral blood count, no significant abnormalities in heart, liver, and kidney functions, and basically normal electrocardiogram; (8) Had no previous chest radiotherapy.
Exclusion Criteria:
(1) Pregnant women, lactating women, or women with reproductive capacity but without contraceptive measures in place; (2) Known to carry mutated susceptibility genes for breast cancer (including BRCA-1 and BRCA-2); (3) Diagnosed with cT4, N3b-c, bilateral breast cancer, with multiple primary lesions, multicentricity or non-bulky enhancement at the primary site; (4) Not receiving the standard neoadjuvant treatment regimen recommended by guidelines, or the primary breast lesion did not achieve pCR (including ypTis) after NAC; (5) Suffering from other malignant tumors or participating in other clinical trials simultaneously; (6) Unable to start radiotherapy within 8 weeks after breast cancer surgery; (7) Diagnosed with distant metastasis through initial imaging or pathology; (8) Previous history of breast cancer, history of radiotherapy in the neck, chest or ipsilateral axilla; (9) Severe non-tumor-related medical comorbidities affecting the implementation of radiotherapy; (10) Suffering from uncontrollable neurological, mental disorders or mental impairments, with poor compliance and inability to cooperate and describe treatment responses.
Primary outcome measure(s)
5-year ipsilateral breast recurrence rate (IBTR) — 5 years The recurrence of the same-sided breast occurred for the first time within 5 years.
5-year local-regional recurrence (LRR) — 5 years Recurrence of the same-side breast, the same-side axillary fossa, the same-side supraclavicular lymph nodes, or the same-side internal mammary lymph nodes for the first time within 5 years.
Trial sites (1)
Facility
City
Region
Status
The First Affiliated with Nanjing Medical University (Jiangsu Province People's Hospital)
Nanjing
Jiangsu
Recruiting
More The First Affiliated Hospital with Nanjing Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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